Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy

NCT07292324 | Completed Phase 4

• 1 other identifier: 2171102008
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if adding a medication called dexmedetomidine to an epidural block works better than a standard epidural to control pain in women undergoing gynecologic laparotomy (abdominal surgery). The main questions it aims to answer are: Does adding dexmedetomidine reduce pain scores and the need for extra pain medicine in the first 24 hours after surgery? Does it lower inflammation levels and reduce the risk of developing chronic pain 3 months later? Participants will receive an epidural (pain medicine delivered through a small tube in the back) combined with general anesthesia for their surgery. Researchers will compare two groups: One group will receive the standard epidural medicine (bupivacaine) mixed with dexmedetomidine. The other group will receive the standard epidural medicine (bupivacaine) alone. Researchers will measure the participants' pain levels, how much pain medicine they use, and blood markers for inflammation for 24 hours after surgery. They will also contact participants 3 months later to check for any long-term pain.

Conditions

Post Operative Pain, Acute; Chronic Post Surgical Pain; Gynecologic Disease

Keywords

Dexmedetomidine; Bupivacaine; Epidural Analgesia; Gynecologic Laparotomy; NF-kappa B

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity (VAS)

  Pain intensity is assessed using the Visual Analogue Scale (VAS). The VAS consists of a 100 mm straight line where the left end indicates "no pain" and the right end indicates "very severe pain" (0-100 mm). Participants mark the line to indicate their pain level. Higher scores indicate worse pain

  6, 12, and 24 hours post-operation

Secondary Outcomes (5)

• Total Bupivacaine Consumption

  24 hours post-operation.

• Total PCEA Demands

  24 hours post-operation.

• Change in Nuclear Factor Kappa B (NFκB) Level

  Baseline (Pre-operative) and 24 hours post-operation.

• Incidence of Chronic Postsurgical Pain

  3 months post-operation.

• Incidence of Bradycardia

  Up to 24 hours post-operation.

Study Arms (2)

Group P1 (Dexmedetomidine Adjuvant)

EXPERIMENTAL

Participants receive epidural analgesia with Bupivacaine 0.1% combined with Dexmedetomidine 0.5 mcg/ml. This is administered as a 10 ml loading dose before incision, followed by a continuous infusion (PCEA) at a rate of 3 ml/hour, with a demand dose of 5 ml and a lockout interval of 30 minutes for 24 hours post-operation.

Drug: Dexmedetomidine & Bupivacaine.

Group P2 (Control)

ACTIVE COMPARATOR

Participants receive epidural analgesia with Bupivacaine 0.1% alone (without adjuvant). This is administered as a 10 ml loading dose before incision, followed by a continuous infusion (PCEA) at a rate of 3 ml/hour, with a demand dose of 5 ml and a lockout interval of 30 minutes for 24 hours post-operation.

Drug: Bupivacain

Interventions

Dexmedetomidine & Bupivacaine. DRUG

Epidural administration of Bupivacaine 0.1% combined with Dexmedetomidine 0.5 mcg/ml. Subjects receive a loading dose of 10 ml before incision. This is followed by a continuous infusion using Patient-Controlled Epidural Analgesia (PCEA) with a background rate of 3 ml/hour, a demand dose of 5 ml, and a lockout interval of 30 minutes for 24 hours post-operation.

Group P1 (Dexmedetomidine Adjuvant)

Bupivacain DRUG

Epidural administration of Bupivacaine 0.1% without adjuvant. Subjects receive a loading dose of 10 ml before incision. This is followed by a continuous infusion using Patient-Controlled Epidural Analgesia (PCEA) with a background rate of 3 ml/hour, a demand dose of 5 ml, and a lockout interval of 30 minutes for 24 hours post-operation.

Group P2 (Control)

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 30-55 years
• ASA physical status I-III
• Body Mass Index (BMI) 18 - 29.9 kg/m2
• Patients undergoing gynecologic laparotomy

You may not qualify if:

• Contraindications for regional anesthesia
• Allergy or contraindication to dexmedetomidine
• Routine use of antidepressants or anticonvulsants
• Chronic opioid consumption (equivalent to \>30 mg oral morphine per day for \>1 month)
• History of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
• Active systemic autoimmune disease or receiving immunosuppressant therapy (e.g., Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis)
• Inability to use the Visual Analogue Scale (VAS) or operate the Patient-Controlled Epidural Analgesia (PCEA) device
• Coagulation disorders (prolonged hemostasis)
• Refusal to participate

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Prof. Dr. I.G.N.G Ngoerah Central General Hospital

Denpasar, Bali, 80114, Indonesia

Location

Related Publications (3)

• Gao Y, Chen Z, Huang Y, Sun S, Yang D. Comparison of dexmedetomidine and opioids as local anesthetic adjuvants in patient controlled epidural analgesia: a meta-analysis. Korean J Anesthesiol. 2024 Feb;77(1):139-155. doi: 10.4097/kja.22730. Epub 2023 May 2.

  PMID: 37127531 BACKGROUND

• Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007/s40261-016-0477-9.

  PMID: 27812971 BACKGROUND

• Hetta DF, Fares KM, Abedalmohsen AM, Abdel-Wahab AH, Elfadl GMA, Ali WN. Epidural dexmedetomidine infusion for perioperative analgesia in patients undergoing abdominal cancer surgery: randomized trial. J Pain Res. 2018 Oct 30;11:2675-2685. doi: 10.2147/JPR.S163975. eCollection 2018.

  PMID: 30464585 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Genital Diseases, Female

Interventions

Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Simson Samuel Soerodjotanojo

  Udayana University

  PRINCIPAL INVESTIGATOR

• I Gusti Ngurah Mahaalit Aribawa

  Udayana University

  STUDY DIRECTOR

• I Made Agus Kresna Sucandra

  Udayana University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: August 21, 2025
• Primary Completion: October 15, 2025
• Study Completion: January 15, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)